Effects of Rocabado's Approach Versus Kraus Exercise Therapy

Temporomandibular Dysfunction Clinical Trial

Official title:

Effects of Rocabado's Approach Versus Kraus Exercise Therapy on Pain and Disability in Patients With Temporomandibular Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05618938
• Other study ID #: REC/RCR & AHS/22/0151 Amna
• Status: Completed
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: February 4, 2023

Study information

• Verified date: April 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TMJ dysfunction is linked to trauma, joint overloading owing to para-functional behaviors, mechanical stress, and metabolic issues. Myofascial pain and dysfunction, functional derangement, and osteoarthrosis are the three most frequent TMJ-related disorders. Temporomandibular joint disorders are a type of craniofacial problems. They affect the temporomandibular joint, muscles of mastication, and other musculoskeletal tissues. The most common clinical sign and symptoms associated with TMJ dysfunction are orofacial pain and clicking. The aim of study will be to compare the effects of Rocabado's approach versus Kraus therapy on Pain and Disability in patients with temporomandibular dysfunction.

Description:

A Randomized Clinical Trial will be conducted at FMH Physiotherapy Clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 40 patients which will be allocated using random sampling through opaque sealed enveloped into Group A and Group B. Group A will be treated with Rocabado's approach and Group B will be treated with Kraus exercises. Outcome measures tools will be conducted through NPRS, TMD disability index, Fonseca questionnaire after four weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 4, 2023
• Est. primary completion date: February 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male and female between the ages of 30 to 60 years

• Patients with jaw pain

• Patients with limited jaw range of motion and associated joint pain

• Patients with TMJ clicking sounds

• Patients with pain upon muscle and joint palpation

Exclusion Criteria:

• Diagnosis of ear, nose, and throat medical pathology underlying the tinnitus;

• Neurological problems that could potentially cause the tinnitus

• Inability to read, understand, and complete the questionnaires or understand and follow commands (e.g., illiteracy, dementia, or blindness)

Related Conditions & MeSH terms

• Temporomandibular Dysfunction
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• Rocabado's approach
Group A will be treated with Rocabado's approach. Rocabado' approach will be comprised of six exercises. Rest position of the tongue Control of TMJ rotation Rhythmic stabilization technique Axial extension of the neck The patients will receive Rocabado's approach consisting 6 repetitions six times a day thrice per week for four weeks
• Kraus exercises
Group B will be treated with Kraus exercises. Kraus exercises will be comprised of eight exercise programs. Tongue position at rest Teeth apart: the patient will be educated to maintain the teeth apart can be therapeutic, which facilitates the resting tongue position Nasal-diaphragmatic breathing Tongue up and wiggle Strengthening Touch and bite: Proprioceptive re-education: Lateral deviation The patients will receive Kraus exercises with the frequency of 2 sets and 10 repetitions twice a day three times per week for four weeks

Locations

Country	Name	City	State
Pakistan	Fatima Memorial Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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Ernst M, Schenkenberger AE, Domin M, Kordass B, Lotze M. Effects of centric mandibular splint therapy on orofacial pain and cerebral activation patterns. Clin Oral Investig. 2020 Jun;24(6):2005-2013. doi: 10.1007/s00784-019-03064-y. Epub 2019 Sep 13. — View Citation

Lopez-Martos R, Gonzalez-Perez LM, Ruiz-Canela-Mendez P, Urresti-Lopez FJ, Gutierrez-Perez JL, Infante-Cossio P. Randomized, double-blind study comparing percutaneous electrolysis and dry needling for the management of temporomandibular myofascial pain. Med Oral Patol Oral Cir Bucal. 2018 Jul 1;23(4):e454-e462. doi: 10.4317/medoral.22488. — View Citation

Lora VR, Canales Gde L, Goncalves LM, Meloto CB, Barbosa CM. Prevalence of temporomandibular disorders in postmenopausal women and relationship with pain and HRT. Braz Oral Res. 2016 Aug 22;30(1):e100. doi: 10.1590/1807-3107BOR-2016.vol30.0100. — View Citation

Matsubara R, Yanagi Y, Oki K, Hisatomi M, Santos KC, Bamgbose BO, Fujita M, Okada S, Minagi S, Asaumi J. Assessment of MRI findings and clinical symptoms in patients with temporomandibular joint disorders. Dentomaxillofac Radiol. 2018 May;47(4):20170412. doi: 10.1259/dmfr.20170412. Epub 2018 Feb 22. — View Citation

Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151. — View Citation

Scrivani SJ, Khawaja SN, Bavia PF. Nonsurgical Management of Pediatric Temporomandibular Joint Dysfunction. Oral Maxillofac Surg Clin North Am. 2018 Feb;30(1):35-45. doi: 10.1016/j.coms.2017.08.001. — View Citation

Seifi M, Ebadifar A, Kabiri S, Badiee MR, Abdolazimi Z, Amdjadi P. Comparative effectiveness of Low Level Laser therapy and Transcutaneous Electric Nerve Stimulation on Temporomandibular Joint Disorders. J Lasers Med Sci. 2017 Summer;8(Suppl 1):S27-S31. doi: 10.15171/jlms.2017.s6. Epub 2017 Aug 29. — View Citation

Slade GD, Bair E, Greenspan JD, Dubner R, Fillingim RB, Diatchenko L, Maixner W, Knott C, Ohrbach R. Signs and symptoms of first-onset TMD and sociodemographic predictors of its development: the OPPERA prospective cohort study. J Pain. 2013 Dec;14(12 Suppl):T20-32.e1-3. doi: 10.1016/j.jpain.2013.07.014. — View Citation

Yadav S, Yang Y, Dutra EH, Robinson JL, Wadhwa S. Temporomandibular Joint Disorders in Older Adults. J Am Geriatr Soc. 2018 Jul;66(6):1213-1217. doi: 10.1111/jgs.15354. Epub 2018 May 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale (NPRS)	The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.; pre and post followup on 4th week	4th week
Primary	Temporomandibular Joint Disability Index Questionnaire:	The TMD Disability Index is a ten-question questionnaire that is based on the Oswestry Back Pain Questionnaire and the Neck Pain and Disability Questionnaire. 12 It is TMJ-specific, comprising specialized TMJ tasks (instrument playing, speech, dental care, and so on); it delivers a score ranging from 20 to 100.; pre and post followup on 4th week	4th week
Primary	Fonseca's Questionnaire for severity	TMD diseases are classified using the Fonseca questionnaire into mild, moderate, severe, or no disease. It consists of ten questions about temporomandibular joint pain, head, back, and chewing discomfort, parafunctional habits, movement limits, joint clicking, perception of malocclusion, and emotional stress sensation.; pre and post followup on 4th week	4th week